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The Ultima system uses the direct measurement of oxygen uptake to objectively and noninvasively assess cardiac and pulmonary function during exercise. The system can be used to screen for early signs of cardiac and pulmonary dysfunction; differentiate heart and lung disease; assess dyspnea complaints; classify patients according to severity of disease as a guide for patient management; establish an optimal exercise prescription and training program; evaluate the efficiency of prescribed therapy.

The Ultima system uses the direct measurement of oxygen uptake and carbon dioxide production to provide nutritional assessment, to optimize nutritional supplements and quantify substrate utilization.

The Ultima system can also provide direct Fick determination of cardiac output using real time oxygen uptake measurements.

The Ultima system is a cardiopulmonary exercise system that provides breath by breath measurements of flow, oxygen uptake and carbon dioxide production.

The Medgraphics Ultima System, categorized as an Oxygen Uptake Computer, has been found substantially equivalent to its predicate device, the Medgraphics Desktop Diagnostic System with 15% CO2 Analyzer (K955432).

Here's an analysis of the acceptance criteria and the study that supports the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: 11 Ultima systems were used for laboratory testing.
• Data Provenance: The document does not explicitly state the country of origin. It is implied to be internal laboratory testing conducted by Medical Graphics Corporation. The study is retrospective, as it compares the new Ultima system to a previously marketed predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

• The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. The study relies on direct comparison to the predicate device's output and internal laboratory testing.

4. Adjudication Method for the Test Set:

• The document does not describe an adjudication method for the test set. The evaluation focuses on the direct comparison of performance metrics (VO2, VCO2, tidal volume) between the Ultima system and the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this is a device for physiological measurement (Oxygen Uptake Computer), not an imaging or diagnostic AI system requiring human interpretation comparison. This device provides quantitative data, not interpretations that would be compared to human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, the study primarily represents standalone algorithm/device performance. The laboratory testing assessed the device's output and precision independently, comparing it to a predicate device. While a human operates the device, the performance evaluation itself is based on the device's measured outputs compared to established benchmarks or the predicate.

7. The Type of Ground Truth Used:

• The ground truth in this study is based on the performance and output of the legally marketed predicate device (Medgraphics Desktop Diagnostic System with 15% CO2 Analyzer, K955432), as well as the inherent physiological measurements (VO2, VCO2, tidal volume) for which the device is designed to accurately measure. The "less than 3% variability" indicates an acceptable deviation from the predicate's established measurements.

8. The Sample Size for the Training Set:

• The document does not mention a separate "training set" in the context of machine learning or AI development. For a physiological measurement device like this, the "training" would typically refer to the calibration, design, and internal validation processes during its development, which are not detailed as a distinct "training set" here.

9. How the Ground Truth for the Training Set Was Established:

• As a "training set" is not explicitly mentioned, the method for establishing its ground truth is not provided. For a device of this nature, the "ground truth" during development and calibration would likely rely on established physiological models, controlled gas mixtures, and comparison to highly accurate reference instruments.

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